The following data is part of a premarket notification filed by Appasamy Associates (u.s.a.), Inc. with the FDA for Operating Microscope Aa Om 10.
| Device ID | K941399 |
| 510k Number | K941399 |
| Device Name: | OPERATING MICROSCOPE AA OM 10 |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | APPASAMY ASSOCIATES (U.S.A.), INC. 193 ROCK RIDGE RD. Millersville, MD 21108 |
| Contact | Srini V Srinivasan |
| Correspondent | Srini V Srinivasan APPASAMY ASSOCIATES (U.S.A.), INC. 193 ROCK RIDGE RD. Millersville, MD 21108 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-04-22 |